Embracing Medicines Development as a Profession.

Abstract

Medicines development has dramatically transformed in the preceding decades. It has evolved from a task undertaken by a small team to a complex series of activities, involving several functions and qualified professionals, across multiple, interrelated, scientific disciplines, worldwide. Conceptualized as a medical specialty, concerned with the research, development, and monitoring of medicines, and spearheaded largely by pharmaceutical physicians, the discipline has extended to embrace non-medically qualified scientists progressively taking on traditional roles within the medicines development ambit. There is expanded engagement of professional backgrounds. Each individual function contributes unique expertise and skills, but they all share a sense of identity, a collective commitment, and a common goal of improving human health and well-being, through innovative treatments. At the same time, milestone advancements in the research and development environment, in healthcare delivery, the regulatory ethos, data sharing with greater transparency, the exponential digitalization, and the emphasis on patient outcomes have imposed greater accountability in systems and processes, and across all global stakeholders. Increasingly, this demands a joint purpose, fostering continuous learning, and engendering a professional identity within the medicines development community, a coinage gaining incremental affirmation as equivalent to pharmaceutical medicine. The aligned set of related competencies and capabilities across the multi-professional teams involved, the sense of identifying concurrently across different, albeit complementary, communities of practice, the obligation of ongoing specialized knowledge training, the mandated enterprise-wide codes of ethics and moral conduct, and the intertwined career paths within the larger business organizational construct of academic institutions, regulatory agencies, and the biopharmaceutical industry-all profess to meet the criteria, and merit medicines development/pharmaceutical medicine be acknowledged, regarded, and recognized as a distinct profession of stature, in its own standing. The concept of pharmaceutical medicine has been floated since 1957, and has received considerable attention in scientific literature over the years. Yet, the discipline struggles to be universally understood and appreciated. This perspective scrutinizes related engendering influences and hindering elements, while advocating the furtherance of medicines development from a traditional occupation, emerging as a vocation, and transforming into a mature profession, with the vision and purpose of advancing better medicines for improved health outcomes for people, globally.